Non-Prescription Drugs Quality Assurance

Non-Prescription Drugs Quality Assurance

NON-PRESCRIPTION DRUGS QUALITY ASSURANCE

According to the authors of the herbal guide titled Rational Phytotherapy, the production of medicines and pharmacologic approach to the treatment of diseases begin with the use of herbs (Hansel etal., 2001). Prior to 1800 when medicine enters the scientific age, traditional herbal medicine is the standard resource for all textbooks in pharmacology (Hansel etal, 2001). Following the advent of medical science, phytotherapy is relegated to the status of an alternative therapy. However, considering historical record, it’s incorrect to categorize phytotherapy as a special or alternative branch of medicine (Hansel etal, 2001).

 Considering that the history of herbal medicine extends to more than 2000 years from antiquity to modern times, it’s appropriate to assume that medicinal herbs used during this period are not only effective but are also devoid of serious toxic side effects. Otherwise, they wouldn’t have been diligently passed down through many cultures to the present time (Hansel etal, 2001). Current commonly used pharmaceutical products are derivatives of pre-existing herbal plants such as the coca shrub that yields cocaine, Cinchona species that yield quinine, digitalis leaf that yields digoxin, the willow bark that yields acetylsalicylic acid or aspirin, and capsicum from paprika extract (Hansel etal, 2001).

According to Hansel etal (2001), among the hundreds of medicinal plants used pharmacotherapeutically today, a small number accounts for a very large percentage of the total drug sales, 55% in the United States. Some are thoroughly investigated while some are currently under study.

Irrespective of the fact that phytotherapy is categorized as an alternative therapy in a 1976 German drug law, phytotherapy is scientifically tested and determined as a treatment approach in which modern pharmacotherapy has its roots (Hansel etal, 2001).

Quality Assurance in Non-Prescription Products

Standardized chemical analyses are necessary to ensure the optimum bioequivalence of plant extracts. This applies to the dried herbs, extracts, as well as the finished products. The study of nonprescription products including dietary supplements, and herbs provides enormous reward from the vast knowledge acquired to recommend the effective and appropriate product for patients. According to Pray (2016), the study of nonprescription products is neither a pure science nor a basic science but rather, an applied study covering different disciplines.

Currently, the status of the study of nonprescription products is comparable to the status of pharmacology and pharmacy management years ago. The study of nonprescription products derives information from various pharmacy disciplines, text extracts include knowledge  from pharmacology, medicinal chemistry, pharmaceutics, and toxicology etc. (Pray, 2016). According to Pray (2016), the FDA OTC-product review restricts the freedom of manufacturers to make claims over the superiority of their products based on ingredients or the anticipated  therapeutic benefit.

 Most nonprescription or over the counter products are advertised and distributed to consumers directly, bypassing pharmacists (Pray, 2016). Considerable information is provided on nonprescription product labels. However, about 40%  of American consumers do not read the the product labels. According to Pray (2016), the FDA proposes the review of the nonprescription products label in 1997. The goal is to improve the legibility by providing product information in different formats. The improved labeling format includes:

·         Content Requirements

·         Format Requirements

The information covered includes drug facts, active ingredients, and inactive ingredients, specified dosage and usage, directions such as tablet, 5-ml teaspoonful etc.

 

References

Hansel, R., Shulz, V., & Tyler, V.E. (2001). Rational Phytotherapy: A Physicians’ Guide to Herbal Medicine (4th ed ). Springer-Verlag

PDR 29th Edition (2007). PDR for Nonprescription Drugs, Dietary Supplements, and Herbs. Thomson Healthcare Inc. Montvale, NJ 07645-1725

Pray, W.S. (2016). Nonprescription Product Therapeutics. Http://www.lww.com